Clinical Trials"Inoperable" does not mean "untreatable".

What are clinical trials?

In cancer research, a clinical trial is a study conducted with cancer patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help cancer patients.

The search for good cancer treatments begins with basic research in laboratory and animal studies. The best results of that research are tried in patient studies, hopefully leading to findings that may help many people.

Before a new treatment is tried with patients, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed, and, as much as possible, shows how to use them safely and effectively. But this early research cannot predict exactly how a new treatment will work with patients. With any new treatment there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more and more information is gained about a new treatment, its risks, and how well it may or may not work.

Standard treatments, the ones now being used, are often the base for building new, hopefully better treatments. Many new treatments are designed on the basis of what has worked in the past, in efforts to improve on this.

Only patients who wish to, take part in a clinical trial. You may be interested in or asked to enter a trial. Learn as much as you can about the trial, before you make up your mind.

The National Cancer Program & Clinical Trials

A nationwide effort to conquer cancer intensified with the National Cancer Act of 1971. As a result of the National Cancer Program, created by that legislation, more cancer patients are being cured today than ever before, and many others are living longer with improved quality of life.

The National Cancer Program brings together a network of researchers at many public and private institutions around the country. These include the National Cancer Institute, cancer centers, universities, community hospitals and private industry. Groups involving hundreds of researchers are working to discover and put to use new knowledge to benefit the cancer patients of today and tomorrow.

Knowledge gained from research studies with patients-clinical trials-has been essential to overall progress. Such studies have led to increased survival for childhood cancers, Hodgkin's disease, breast, uterine, testicular and bladder cancers, as well as others. These studies continue to play a key role in progress against cancer.

Today, major scientific discoveries in the laboratory are part of a revolution in biology. New tools to unravel the process of cancer are leading to exciting new approaches against cancer. Clinical trials continue to be the link between such basic research and patients. The goal is to translate the best of that research into findings that directly help people.

What are the risks/side effects, if any, in clinical trials?

The treatments used in clinical trials can cause side effects and risks depending on the type of treatment and the patient's condition. Side effects vary from patient to patient.

Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though efforts have been made to find out what they might be. For this reason, trials can carry unknown dangers and side effects as well as hoped-for benefits. Patients need to know what is involved in a study-what side effects may be expected-and, as much as possible, what "unknowns" or uncertainties they may be facing.

You will be told about the treatments being tested and will be given a form to read that discusses the risks and hoped- for benefits. If you agree to take part, you will be asked to sign a form, called the informed consent form. Before you sign, be sure you understand what risks you face. Ask the doctor or nurse to explain any parts of the form or the trial that are not clear. If you do not want to be in the trial, you may refuse. Even if you sign the form, you are free to leave the trial at any time and can receive other available medical care.

In clinical trials, most side effects are temporary and will gradually go away once treatment is stopped. For example, some anticancer drugs cause hair loss and nausea and some do not. They can also affect the bone marrow which produces blood cells. During treatment, the number of blood cells, called blood counts, may fall too low. Since this could lead to possible infection or other problems, patients have their blood counts checked often. Luckily, bone marrow has a great ability to replace blood cells, so that blood counts can usually return to normal.

Some side effects in clinical trials can be permanent and serious, even life-threatening. Also, certain side effects may not appear until later, after the treatment itself is over. (These "late" effects may include damage to a major organ like the heart, lungs, or kidneys; sterility; or a second cancer.) Many cancer patients are now living longer, largely because of better treatments. Researchers are concerned and trying to prevent late complications of treatments.

As a patient, it can be hard to decide about your treatment. There are a number of things to consider. Cancer is a life- threatening disease which causes symptoms of its own that are not related to treatment. In each case, the unavoidable risks of the cancer itself, and your condition, should be weighed against the potential risks and benefits of a new research treatment. Standard treatments, as well as treatments in clinical trials, can also cause side effects and risks.

What questions should I ask my doctor if I am considering a clinical trial?

If you are thinking about taking part in a clinical trial, here are some important questions to ask:

What is the purpose of the study?

What does the study involve?

What kinds of tests & treatments? (Find out what is done & how it is done.)

What is likely to happen in my case with or w/o this new research treatment? (What may the cancer do and what may this treatment do?)

What are other choices and their advantages and disadvantages? (Are there std. treatments for my case & how does the study compare with them?)

How could the study affect my daily life?

What side effects could I expect from the study? (There can also be side effects from standard treatments and from the disease itself.)

How long will the study last? (Will it require an extra time commitment?)

Will I have to be hospitalized? If so, how often and for how long?

Will I have any costs? Will any of the treatment be free?*

If harmed as a result of the research, what treatment would I be entitled to?

What type of long-term follow-up care is part of the study?

*Costs are a major concern of patients and families. Different arrangements and policies exist at different institutions and, of course, insurance coverage varies. Patients should freely discuss what costs are involved in their cases ahead of time. If you need financial aid, contact the hospital social services office, the Cancer Information Service, or the local American Cancer Society Chapter. They may be able to direct you to a source of help.